*Content reviewed by HotPause Health  Medical Advisor and OBGYN, Dr. Beverly Joyce.

Meet Lynkuet: A Non-Hormonal Game Changer For Hot Flashes

If you’re navigating the ups and downs of menopause, you know how disruptive hot flashes and night sweats can be – waking you up, interrupting work, throwing off your day or night. The good news: you now have another non-hormonal option.

On October 24, 2025, the Food and Drug Administration (FDA) approved elinzanetant (brand name Lynkuet) for moderate to severe vasomotor symptoms (VMS) — i.e., hot flashes and night sweats due to menopause.

Why it matters

• Many women prefer to avoid hormone therapies, whether because of personal choice, health history (e.g., breast cancer, cardiovascular risk), or side-effect concerns.
  
• Until recently, non-hormonal options were limited. That’s changed. Lynkuet adds a powerful new tool to the toolbox.
  
• Studies show it can meaningfully reduce how often hot flashes happen and how severe they are. One large trial found more than a 73% reduction in frequency/severity of hot flashes by week 12.
  

How Lynkuet works (without hormones)

• It is the first dual neurokinin-1 (NK1) and neurokinin-3 (NK3) receptor antagonist approved for VMS.
  
• Here’s the gist: When estrogen levels drop in midlife, certain neurons in the brain’s temperature regulation center (“KNDy” neurons) become over-active and trigger hot flashes/night sweats. Lynkuet blocks key signals (NK1 + NK3) in those pathways, helping bring the thermostat back toward normal.
  
• It’s taken once a day, at bedtime, making it convenient and aligned with the reality that many of us experience nighttime sweats.
  

What The Data Show: Effectiveness & Timing

• In the pivotal Phase 3 “OASIS” studies (OASIS-1/2/3), Lynkuet showed statistically significant reductions in both the number and severity of hot flashes by weeks 4 and 12 compared to placebo.
  
• In one long-term (52-week) study, women maintained reductions in hot flashes and night sweats, and saw improvements in sleep disturbance and quality of life. 
• The bottom line: If you decide to try it, meaningful relief can start early (by ~4 weeks) and continue over months.
  

Who Might Benefit From Lynkuet

You might consider discussing Lynkuet with your clinician if:

• You’re experiencing moderate-to-severe hot flashes/night sweats due to menopause that are affecting your quality of life.
  
• You prefer to avoid hormones (or have a medical reason why hormones aren’t ideal).
  
• You’re willing to work with your clinician on baseline labs and monitoring.
• You are not pregnant or trying to become pregnant, and are willing to use effective contraception if applicable.
  

Safety & Side Effects

While Lynkuet is non-hormonal, it still has important safety considerations. These should be part of your discussion with your clinician or menopause specialist. Among the key points:

• Common side-effects include headache, fatigue, dizziness or sleepiness.
  
• Because it may cause sleepiness, drowsiness, or dizziness, it’s taken at bedtime, and you should be cautious about driving or operating heavy machinery until you know how you respond.
  
• Liver monitoring is part of the safety routine. While Lynkuet doesn’t carry the same boxed liver-injury warning as some older agents, there are transaminase elevation risks, and baseline plus periodic lab checks are recommended.
  
• Not recommended during pregnancy as studies suggest risk of pregnancy loss/stillbirth. Effective contraception is important if you are of reproductive potential.
  

When & How To Access It

• Lynkuet is expected to be available in the U.S. starting November 2025.
  
• The wholesale price has been reported around ~$625/month, but assistance programs may reduce your cost significantly — in some cases to ~$25/month depending on eligibility and insurance. 
• As with many newer meds, availability and coverage may vary: check with your insurance/health plan, pharmacy, and clinician to understand patient cost, prior-authorization needs, etc.
  

What To Ask Your Clinician

Here are smart questions to bring to your appointment:

• “Based on my health history, medication list and what I’ve already tried, is Lynkuet a good fit for me?”
  
• “What baseline labs do we need and what’s the monitoring plan?”
  
• “How long should we try it before assessing effectiveness? What counts as success?”
  
• “What are the side-effects or risks in the context of my personal health (e.g., seizure risk, liver, other meds)?”
  
• “What will my out-of-pocket cost be, and are any patient assistance programs available?”
  
• “What happens if it doesn’t work or if I experience side-effects, what are my next steps?”
  

Final thoughts

Menopause is a deeply personal transition but disruptive hot flashes and night sweats don’t have to simply be endured. With the FDA approval of Lynkuet (elinzanetant), you now have a robust non-hormonal option to discuss with your clinician, one backed by solid data and designed to ease both day and night symptoms.

At HotPause Health, our focus is helping women find evidence-based, tailored solutions so you can live your best life through perimenopause and beyond. If hot flashes are holding you back, this is a timely moment to re-explore your options.